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Recruiting NCT06527872

Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN

— Observational Lupus Nephritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None (Observational study).
Who it may be relevant to
Registry conditions: Lupus Nephritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Italy, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study

Overview

The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.

Detailed description

This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.

Interventions

  • Other None (Observational study)
    Not Applicable since Observational Study

Primary outcome measures

  • Number of Participants Maintaining Renal Function (Less than Equal to [<=] 30 Percentage [%] Decline in Estimated Glomerular Filtration Rate [eGFR] from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy [Time frame: At Month 24]
Secondary outcome measures (7)
  • Number of Participants Achieving Modified Partial Renal Response (<=20% Decline in eGFR and <=0.7 Urine Protein-Creatinine Ratio [uPCR]) and Modified Complete Renal Response (<=10% Decline in eGFR and <=0.5 uPCR) [Time frame: At Months 24 and 60]
  • Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy (in Those that Remain Adherent to Belimumab) at Month 24 [Time frame: At Month 24]
  • Change in the Daily Dose of Steroid (in milligrams per day) from the Initiation of Belimumab [Time frame: Baseline (Day 1) to Month 60]
  • Estimated Glomerular Filtration Rate (eGFR) Slope over Time [Time frame: Up to Month 60]
  • Time to Achieving eGFR 30% and 40% Reduction [Time frame: Up to Month 60]
  • Time to Initiating Renal Replacement Therapy [Time frame: Up to Month 60]
  • Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy [Time frame: At Month 60]

Eligibility criteria

Inclusion criteria

  • Participants to provide a signed informed consent at the time of enrollment per protocol,
  • Male or female aged 18 or over at initiation of belimumab,
  • Participants received belimumab in any formulation (subcutaneous or intravenous) for the treatment of active LN prescribed as per local label in combination with standard immunosuppressive therapy/ies at initiation of belimumab,
  • Participants initiated belimumab 6 to 24 months prior to study enrollment,
  • Accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy at any time prior to belimumab initiation),
  • Biopsy-confirmed LN diagnosis at any time prior to belimumab initiation for treatment of LN
  • Class III (focal LN) with or without Class V (membranous LN),
  • Class IV (diffuse LN) with or without Class V,
  • Class V.

Exclusion criteria

  • Participants receiving renal replacement therapy (i.e., dialysis, kidney transplant, or those in end-stage kidney disease) at initiation of belimumab,
  • Participant is concomitantly receiving another SLE targeted monoclonal antibody (MAb), or a MAb expected to compromise immune responses, at initiation of belimumab,
  • Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies),
  • Participant is pregnant at the initiation of belimumab,
  • Participant with a kidney transplant at the initiation of belimumab,
  • Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • GSK Investigational Site — Baltimore
  • GSK Investigational Site — Charlotte
  • GSK Investigational Site — Columbus
  • GSK Investigational Site — Hixson
France · 1 center
  • GSK Investigational Site — Marseille
Italy · 1 center
  • GSK Investigational Site — Rozzano
Japan · 1 center
  • GSK Investigational Site — Fukuoka

Identifiers

NCT: NCT06527872 · 216147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗